2013 has been a crucial year for the Indian pharmaceutical industry as most of the top pharmaceutical companies had serious allegations related to 'data-fudging’ reported by FDA's Centre for Drug Evaluation and Research.
Major issues noticed by the regulators during inspection include:
Established laboratory controls are not followed and data is not recorded at the time of performance
Deviations from written test procedures are not recorded and justified
Employees are not given training in current good manufacturing practices
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards
Keeping in mind these critical challenges and working towards the best interest of Indian pharma companies, CPhI conferences in association with Lachman Consultants brings you a timely workshop focused on Data Integrity, Reliability & Quality Metrics from 9-10 September, 2014 in Hyderabad and from 11- 12 September, 2014 in Mumbai
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